Risk and Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL) (MBL RiskConseq)

May 10, 2024 updated by: Geffen Kleinstern, University of Haifa

Immune Biomarkers, Genetic Risk, and the Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL)

The aim of this proposal is to identify immune biomarkers, genetic risk, and the clinical consequences of low count monoclonal B-cell lymphocytosis (LC MBL), a common premalignant condition affecting up to 17% of European adults age>40. LC MBL is a precursor to chronic lymphocytic leukemia (CLL), characterized by a circulating population of clonal B-cells. It is relatively understudied, despite emerging evidence of clinical consequences such as increased risk for life-threatening infections and lymphoid malignancies. Studies reported that male sex, age, family history of CLL, and CLL-susceptibility genetic loci were associated with LC MBL risk. These findings were reported in European ancestry individuals and have not been generalized to other thnicities. This study will provide this missing knowledge using a unique multi-ethnic Israeli population of Jews and Arabs that have one of the highest and lowest age-standardized incidence rates of CLL in the world, respectively, and characterized with different genetic backgrounds.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Jewish and Arab individuals over the age of 40 attending to the Clalit HMO clinics in the North of Israel for regular blood tests

Description

Inclusion Criteria:

  • Individuals over the age pf 40

Exclusion Criteria:

  • Individuals with lymphoproliferative disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Clalit Health Services
Individuals over the age of 40 attending to the Clalit HMO clinics in the North of Israel for regular blood tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the relationship between LC MBL and life-threatening infections, hematologic malignancies, and solid tumors among Jews and Arabs in Israel
Time Frame: From enrollment and 15 years of follow up
Blood samples will be screened for MBL using flow cytometry, while data on the various outcomes will be collected from electronic medical records from Clalit Health Services.
From enrollment and 15 years of follow up
Assess the relationship between LC MBL and cardiovascular diseases, autoimmune conditions, and Alzheimer among Jews and Arabs in Israel
Time Frame: From enrollment and 15 years of follow up
Blood samples will be screened for MBL using flow cytometry, while data on the various outcomes will be collected from electronic medical records from Clalit Health Services.
From enrollment and 15 years of follow up
Identify germline genetic factors that are associated with LC MBL risk among Jews and Arabs in Israel
Time Frame: The first 5 years of the study
DNA will be extracted from the blood sample and sequenced.
The first 5 years of the study
Evaluate the prevalence of LC MBL by Jews and Arabs and by sex in Israel.
Time Frame: The first 5 years of the study
Blood samples will be screened for MBL using flow cytometry, ethnicity and sex will be determined using a demographic questionnaire
The first 5 years of the study
Identify immune biomarkers that are associated with LC MBL risk
Time Frame: The first 5 years of the study
Blood sample will be screened for MBL using flow cytometry, and immune biomarkers will be screened from plasma samples.
The first 5 years of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the relationship between LC MBL and other clinical conditions
Time Frame: From enrollment and 15 years of follow up
Other clinical conditions will be determined from electronic medical records from Clalit Health Services
From enrollment and 15 years of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Haifa

Collaborators

Bnai Zion Medical Center
Clalit Health Services, Haifa and West Galilee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

December 1, 2040

Study Completion (Estimated)

December 1, 2040

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBL_RiskCons

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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